Positive Aerin Medical AERWAY Study Results Published Showing Effectiveness of VivAer® for Nasal Obstruction Patients With Nasal Valve Collapse

SUNNYVALE, Calif.--(BUSINESS WIRE)-- Aerin Medical, Inc., a company dedicated to providing Ear Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal airway conditions, today announced the publication of the AERWAY study showing the safety and efficacy of VivAer^® for treating patients with nasal airway obstruction (NAO) due to nasal valve collapse (NVC). In the study, published in the Journal of Otolaryngology and Rhinology, patients experienced significant nasal obstruction symptom improvements at three months following treatment. The AERWAY study adds to a growing body of evidence supporting the safety and efficacy of VivAer.

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Published data demonstrate significant improvement in nasal obstruction symptoms at three months for patients with nasal valve collapse, following treatment with VivAer®. VivAer, a non-invasive technology developed by Aerin Medical Inc., uses temperature-controlled radiofrequency energy to provide long-term relief from nasal obstruction. (Photo: Business Wire)

“Nasal valve collapse is a common problem for the 20 million Americans suffering from nasal airway obstruction, but treatment options have historically been limited for otolaryngologists (ENT physicians),” said William Yao, M.D., the study’s principal investigator from the Department of Otorhinolaryngology - Head and Neck Surgery at McGovern Medical School at The University of Texas Health Science Center at Houston. “For patients who don’t respond to medications, temporary aids like breathing strips may not be practical, and traditional surgical procedures in the operating room have had a limited role. The results of this study showed that temperature-controlled radiofrequency energy could be a reliable and effective treatment.”

The AERWAY study, a prospective, multi-center single-arm trial, enrolled 122 adult patients with severe or extreme Nasal Obstruction Symptom Evaluation (NOSE) scores, for whom NVC was a primary or significant contributor. Data from the AERWAY study show that patients treated with VivAer experienced significant symptom improvements as well as high rates of satisfaction three months following treatment. Among the study population:

• A significant improvement of 59% was observed in mean total NOSE scores from baseline to 3 months (a decrease from 80.3 to 32.9, respectively; p<0.001).
• 91.6% of patients responded to treatment, demonstrating either a 20% improvement in total NOSE score relative to baseline or at least one severity category improvement in their NOSE score.
• 87.3% of patients treated indicated they would recommend VivAer to a friend.

This study will continue to follow up with the patients through two years to evaluate the durability of the procedure’s effects, but the authors noted that three-month results have been shown to be predictive of long-term outcomes in other studies.

“Aerin Medical is committed to working closely with the otolaryngology community and societies to build strong clinical evidence around the use of non-invasive solutions for chronic nasal airway conditions,” said Matt Brokaw, CEO of Aerin Medical. “We appreciate the efforts of dozens of physician investigators involved in clinical trials demonstrating the significant benefits of our products and addressing the growing interest in treating the lateral nasal wall in appropriate patients.”

NAO can take a heavy toll on daily life. The most common symptoms include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion. NVC contributes to nasal obstruction for 73% of highly symptomatic patients,¹ but is often under-diagnosed and left untreated. VivAer offers ENT physicians a unique treatment modality that remodels tissue in the nasal valve.

About VivAer

VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. It is a single solution that is used to treat the lateral nasal wall; it can also treat the turbinates and septal swell bodies that contribute to NAO. VivAer does not involve any cutting, freezing, or removal of nasal tissue or bone. Treatment with VivAer may be performed during a routine office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime, and are often able to return to normal activities immediately following treatment.* The VivAer Stylus received CE Mark in 2016 and FDA 510(k) clearance in December 2017.

About Aerin Medical

Aerin Medical is a privately held, venture-backed company, with U.S. offices in Sunnyvale, California and Austin, Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal airway conditions. The company’s products, VivAer^® for nasal airway obstruction and RhinAer^® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with in-office procedures performed with local anesthetic. More than 40,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Twitter and LinkedIn.

*Individual results may vary.

¹ Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6)

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